A Study for the Participants With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Treated With Androgen Deprivation Therapy (ADT) Plus Apalutamide or Enzalutamide
- Conditions
- Metastatic Hormone-sensitive Prostate Cancer
- Interventions
- Registration Number
- NCT05901649
- Lead Sponsor
- Janssen-Cilag Ltd.
- Brief Summary
The purpose of this study is to assess the real-world outcomes differences between apalutamide or enzalutamide plus androgen deprivation therapy (ADT) for the treatment of participants with metastatic hormone-sensitive prostate cancer (mHSPC).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 516
- Must have a histologically or cytologically-confirmed diagnosis of adenocarcinoma of the prostate
- Must have documented metastatic hormone-sensitive prostate cancer (mHSPC)
- Must have agreed with the treating physician the initiation of either apalutamide or enzalutamide (plus androgen deprivation therapy [ADT]) treatment, per the treating physician's decision, prior to enrollment into the study
- Must sign, and/or their legally acceptable representative where applicable must sign, a participation agreement/ informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements
- Must have baseline prostate-specific antigen (PSA) captured within 30 days prior to the first administration of apalutamide or enzalutamide
- Must agree to complete patient-reported outcomes (PROs) during the study, including the baseline ones collected before the first administration of apalutamide or enzalutamide
- Has already received or is currently receiving either apalutamide or enzalutamide, or any other novel hormonal treatments (including but not limited to abiraterone acetate and darolutamide)
- Is currently receiving an active treatment for prostate cancer as part of an interventional study
- Has a progression under ADT treatment (and thus became castrate-resistant) prior to start of apalutamide or enzalutamide treatment
- Has received ADT treatment for mHSPC for more than 2 months prior to apalutamide or enzalutamide treatment initiation or ADT treatment was administered for earlier disease stages within the last 12 months prior to apalutamide or enzalutamide treatment initiation
- Has received prior docetaxel for the treatment of mHSPC
- Participants is not treated in line with current Summary of Product Characteristics for apalutamide or enzalutamide
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Apalutamide Plus Androgen Deprivation Therapy (ADT) Apalutamide Participants with metastatic hormone-sensitive prostate cancer (mHSPC) will be observed who are being treated with apalutamide under clinical practice setting. Only data available per routine clinical practice will be collected within this study. Enzalutamide Plus Androgen Deprivation Therapy (ADT) Enzalutamide Participants with metastatic hormone-sensitive prostate cancer (mHSPC) will be observed who are being treated with enzalutamide under clinical practice setting. Only data available per routine clinical practice will be collected within this study.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Prostate-specific Antigen (PSA) Level <0.2 ng/mL at Month 3 At month 3 Percentage of participants with PSA level less than (\<)0.2 nanogram per milliliter (ng/mL) at month 3 will be reported.
Cognitive Functioning as Assessed by Partial Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) Questionnaire Up to 30 Months Cognitive function of the participants will be measured by the partial FACT-Cog (Version 3) questionnaire. The FACT-Cog score ranges from scale 0-148. The higher the total score, the better the cognitive function.
Health-Related Quality of Life (HRQoL) as Assessed by Partial European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Questionnaire Up to 30 Months HRQoL of the participants will be assessed as partial EORTC QLQ-C30 questionnaire. EORTC QLQ-C30 scale scores range from 0 to 100. A high score for a functional scale represents a high level of functioning, whereas a high score for a symptom scale/single item represents a high level of symptom.
Fatigue as Assessed by Brief Fatigue Inventory-Short Form (BFI-SF) Questionnaire Up to 30 Months Participant fatigue will be assessed by the BFI-SF questionnaire. The BFI-SF score range from scale 0-10. Scores are categorized as Mild (1-3), Moderate (4-6), and Severe (7-10).
Prostate-specific Antigen (PSA) Anxiety as Assessed by Memorial Anxiety Scale for Prostate Cancer (MAX-PC) Questionnaire Up to 30 Months PSA anxiety of the participant will be assessed by the MAX-PC questionnaire. The MAX-PC total score ranges from scale 0 to 54. The MAX-PC is divided into three subscales: a) prostate cancer anxiety (PCA) range from 0 to 33, b) Prostate-Specific Antigen Anxiety (PSAA) ranges from 0 to 9, and c) fear of recurrence (FOR) ranges from 0 to 12.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (53)
Klinikum Wels Grieskirchen
🇦🇹Wels, Austria
Akh Wien
🇦🇹Wien, Austria
Institut Sainte Catherine
🇫🇷Avignon, France
Institut Bergonie
🇫🇷Bordeaux, France
Polyclinique Bordeaux Nord Acquitaine
🇫🇷Bordeaux, France
Clinique Pasteur- Lanroze
🇫🇷Brest, France
Hopital Michallon CHU Grenoble Alpes
🇫🇷La Tronche, France
Hôpital Edouard Herriot
🇫🇷Lyon, France
Centre d'oncologie de Gentilly
🇫🇷Nancy, France
CHU Nimes
🇫🇷Nimes, France
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